Maquet Datascope Corp - Cardiac Assist Division recalls CARDIOSAVE Hybrid IABP and CARDIOSAVE Rescue IABP affected part number is 0998-:XX-0800-XX Li-Ion Battery affected part…

Recall date

December 23, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1386-2017

FDA classification

Class II

Brand / firm

Maquet Datascope Corp - Cardiac Assist Division

Sold / distributed

Worldwide Distribution - US Nationwide

Why it was recalled

Maquet has received 3 confirmed complaints related to the Li-lon Battery used with the Maquet CARDIOSAVE Hybrid IABP and Maquet CARDIOSAVE Rescue IABP of the battery venting after being accidentally dropped.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

CARDIOSAVE Hybrid IABP and CARDIOSAVE Rescue IABP affected part number is 0998-:XX-0800-XX Li-Ion Battery affected part number is 0146-00-0097 Product Usage: The CARDIOSAVE Hybrid Intra-Aortic Balloon Pump (IABP) is an electromechanical system used to inflate and deflate intra-aortic balloons